Multi-Center Prospective Validation Study of VTE Risk Prediction Tool in Trauma Patients

Overview

About this study

Almost one-half million people suffer venous thromboembolism annually in the United States, and one-third die from this disease. Massive bleeding from injury accounts for half of early deaths after trauma. This study aims to prevent the deaths and suffering associated with venous thromboembolism and bleeding by identifying the individual person at high risk of these complications in order to take preventive measures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Trauma patients who arrive at the respective trauma centers for evaluation for acute injuries will be considered for enrollment:

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  • Male and female patients 18 years of age or older (no upper age limit)
  • Male and female patients < 18 years of age or older (who have assented to inclusion and whose parents or legally authorized representatives have signed consent)
  • Blunt trauma patients including those with closed head injury
  • Penetrating trauma patients
  • Subjects meeting all of the above criteria but who are pregnant will also be enrolled but will first require informed consent prior to blood draws

Exclusion Criteria: 

Trauma patients who arrive to ED who:

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  • Are on therapeutic anticoagulation, such as Coumadin or antiplatelet agents (excluding aspirin or ibuprofen).
  • Have preexisting coagulopathy (cirrhosis and inherited thrombophilia)
  • Are patients greater than 12 hours from time of injury
  • Are patients who do not have a blood sample at 12 or less hours, relative to time of injury
  • Have active malignancy, active sepsis, or renal failure requiring dialysis
  • Are patients with burn  or electrical injuries
  • Have known prior history of VTE
  • Are patients who have experienced significant traumatic injuries or major surgery within the past year
  • Are patients on high dose steroids or autoimmune medications
  • Are prisoners
  • Have current injuries from known suicide attempt
  • Do not meet trauma criteria despite initial classification as Yellow or Red trauma.

Eligibility last updated 8/24/122. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Myung Park, M.D., M.S.

Open for enrollment

Contact information:

Derek Vanmeter

(507)286-9040

Vanmeter.Derek@mayo.edu

More information

Publications

Publications are currently not available